Drug-delivering insertable medical devices are used for localized delivery of a drug to a target site in a blood vessel. Drug Eluting Balloon (DEB) is one such drug-delivering insertable medical device. Although, widely used, the DEBs are associated with use of polymers for loading the drug on the surface of the DEBs. The polymers used may cause inflammation at the target site. To avoid the inflammation caused by the polymers, the drug may be loaded on the surface of the DEB without using the polymers. However, such polymer-free approaches known in the art are based on surface modification of the DEB.
Additionally, the DEB comes in contact with the target site in the blood vessel for a very short period, generally, ranging from 30 seconds to 90 seconds. The required amount of the drug loaded on the DEB may not be released from the surface of the DEB within such a short period. Therefore, a higher amount of the drug has to be loaded on the DEB as compared to the amount of the drug actually required to be delivered. As the higher amount of the drug is loaded on the DEB, a substantial amount of the drug may remain on the surface of the DEB after the DEB is withdrawn from the target site. The remaining amount of the drug present on the DEB may get washed away in the blood stream while the DEB is being withdrawn through the blood vessel thereby producing unwanted side effects.
Further, micro-sized drug particles are coated on the current DEBs. The micro-sized particles of the drug may not penetrate tissues at the target site efficiently. Thus, the current DEBs may not exhibit an efficient in-tissue diffusion of the drug.
Therefore, there is a need in the art for a DEB that can efficiently deliver the drug to the target site in the blood vessel within a short period for which the DEB comes in contact with the target site. In addition, there is a need in the art for a DEB that can efficiently deliver drug to the maximum area of a lesion and provide for enhance bioavailability with an optimum amount of the drug loaded on the drug-delivering balloon.